StockMarketWire.com - AstraZeneca said the US Food and Drug Administration (FDA) had rejected the company’s application for its lung disease treatment.

The US Food and Drug Administration (FDA) had issued a complete response letter regarding the New Drug Application (NDA) for the company’s PT010 treatment, an inhaled triple-combination therapy and potential new medicine for patients with chronic obstructive pulmonary disease (COPD).

AztraZeneca said it would now work closely with the FDA regarding next steps, including submitting for review recent results from the second positive Phase III trial, ETHOS, which was not completed at the time the application was submitted.



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